A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)

StatusRecruiting

PhasePhase 1/2

SponsorCabaletta Bio

Started2020-09-29

View on ClinicalTrials.gov ↗

Amendment history

2026-05-28

Study Status, Contacts/Locations v30

Study sitescontacts updated at 1 of 13 sites

2026-05-14

Study Status, Contacts/Locations v29

Study sitescontacts updated at 4 of 13 sites

2025-12-11

Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v28

PhasePhase 1→Phase 1/2

Enrollment target55→40

Study arms1→2

InterventionsDSG3-CAART or CABA-201 (Biological)→CABA-201 (Biological), DSG3-CAART (Biological)

Eligibility criteria+167 characters

Inclusion Criteria for DSG3-CAART: Closed to enrollment Confirmed diagnosis of mPV by prior or screening biopsy and [...] itive at screening Inclusion Criteria for CABA-201 sub-study: Open to enrollment Age ≥18 Confirmed diagnosis of PV by prior or screening biopsy and p [...] r active malignancy (not including non-melanoma skin cancer) or malignancy diagnosed within the previous 5 years Have received rituximab or other anti-CD20 or anti-CD19 the [...] r autoimmune disorder requiring immunosuppressive therapies ~~Investigational~~Treatment ~~treatment~~with inany ~~last~~investigational 3agent ~~months~~within 4 weeks or 5 half-l [...]

Study description+256 characters

[...] , eyelids, anus, and genitals. This phase 1/2 study is being conducted in two parts. The first part is the main study conducted to find the maximum tolerated dose and optimal fr [...] osal PV who are inadequately managed by standard therapies. AThis study is closed to enrollment. The second part is a sub-study ~~will~~is bebeing conducted to investigate if CABA-201, also called resecabtagene autoleucel, or "rese-cel", can be safely administered while achieving clinical responses without the need for preconditioning in mucosal-dominant PV (mPV) and mucocutaneous PV (mcPV) patients. This sub-study is open [...] [...]

Study sitescontacts updated at 2 of 13 sites

2025-03-14

Study Status, Contacts/Locations v27

Study sitesdetails revised at 2 of 13 sites

2025-03-10

Study Status, Contacts/Locations v26

Study sitesdetails revised at 1 of 13 sites

Show 25 earlier versions

2025-01-27

Study Status, Contacts/Locations v25

Study sites12→13

2025-01-17

Study Status, Contacts/Locations v24

Study sites10→12

2025-01-06

Study Status, Contacts/Locations v23

Study sitescontacts updated at 1 of 10 sites

2024-11-11

Study Status, Contacts/Locations v22

Study sitesdetails revised at 1 of 10 sites

2024-11-07

Study Status, Contacts/Locations v21

Study sitesdetails revised at 3 of 10 sites

2024-10-25

Study Status, Contacts/Locations v20

Study sitesdetails revised at 4 of 10 sites

2024-08-21

Study Status, Contacts/Locations v19

Study sitesdetails revised at 6 of 10 sites

2024-08-07

Study Status, Contacts/Locations v18

Study sitescontacts updated at 1 of 10 sites

2024-07-19

Study Status, Contacts/Locations v17

Re-verified, no change to tracked fields

2024-05-20

Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v16

Primary completion date2026-09→2029-01

Completion date2026-09→2029-01

Enrollment target39→55

InterventionsDSG3-CAART (Biological)→DSG3-CAART or CABA-201 (Biological)

Eligibility criteria+672 characters

[...] at screening Anti-DSG3 antibody ELISA positive at screening Inclusion Criteria for CABA-201 sub-study Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and/or DIF PV inadequately managed by at least one standard immunosuppressive therapy Active PV at screening DSG3 ELISA positive at screening Exclusion Criteria: Active cutaneous lesions associated with [...] munosuppressive therapies Investigational treatment in last 63 months ~~Absolute~~Exclusion ~~lymphocyte~~Criteria ~~count~~for <CABA-201 ~~1,000~~sub-study Have paraneoplastic pemphigus or active malignancy (not includin [...] [...]

Secondary endpoints9 to 14 entries

For CABA-201 Sub-study: To evaluate adverse events reported by subjects For CABA-201 Sub-study: To characterize the pharmacodynamics (PD) For CABA-201 Sub-study: To characterize the pharmacokinetics (PK) For CABA-201 Sub-study: To evaluate autoantibody -related biomarkers For CABA-201 Sub-study: To [...]

Primary endpoints1 to 2 entries

For CABA-201 Sub-study: To evaluate adverse events reported by subjects

Study description+724 characters

Pemphigus vulgaris (PV) is a B-cell mediated autoimmune disorder in which painful blisters are formed on the skin or mucosal membrane, including the mouth, nose, throat, eyelids, anus, and genitals. This phase 1/2 study is being conducted to find the maximum tolerated dose and optimal fractionated i [...]

Study sitesdetails revised at 4 of 10 sites

Study title+149 characters

A Phase 1/2, Open-label, Safety and Dosing Study ~~to Determine the Maximum Tolerated Dose~~ of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in ~~Mucosal-dominant~~Subjects PVWith ~~Patients~~Active, Pemphigus Vulgaris (~~mPV~~RESET-PV)

2023-05-04

Study Status, Arms and Interventions v15

Re-verified, no change to tracked fields

2022-11-30

Study Status, Contacts/Locations v14

Study sitesdetails revised at 1 of 10 sites

2022-10-03

Study Status, Study Design, Arms and Interventions v13

Enrollment target30→39

2022-06-15

Study Status, Contacts/Locations v12

Study sitesdetails revised at 1 of 10 sites

2022-06-09

Study Status, Contacts/Locations v11

Re-verified, no change to tracked fields

2022-05-18

Study Status, Arms and Interventions, Contacts/Locations v10

Study sites8→10

2022-03-24

Study Status, Contacts/Locations v9

Study sites7→8

2021-10-08

Study Status, Contacts/Locations v8

Study sitescontacts updated at 1 of 7 sites

2021-09-27

Study Status, Contacts/Locations v7

Study sites5→7

2021-09-23

Study Status, Arms and Interventions, Contacts/Locations v6

Study sites3→5

2021-01-22

Study Status, Eligibility, Contacts/Locations v5

Primary completion date2026-08→2026-09

Completion date2026-08→2026-09

Start date2020-08-01→2020-09-29

Study sites2→3

Eligibility criteria+211 characters

Inclusion Criteria: Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA mPV inadequately managed by at least ~~two~~one standard immunosuppressive therapies Active mPV at screening Anti-DSG3 antibody ELISA positive at screening Exclusion Criteria: ~~Cutaneous~~Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease Rituximab in last 612 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased Prednisone > 0.25mg/kg/day Other autoimmune disorder requir [...]

2020-10-20

Study Status, Contacts/Locations v4

Re-verified, no change to tracked fields

2020-09-21

Study Status, Contacts/Locations v3

Start dateestimated 2020-08→confirmed 2020-08-01

Study sites1→2

2020-07-16

Study Status v2

Start date2020-09→2020-08

2020-06-29

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Study sitesdetails revised at 1 of 1 site

2020-06-05

Original filing

Cabaletta Bio

6 trials monitored

See 1 trial at risk

A phase 1/2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells \[DSG3-CAART\] or CD19-specific Chimeric Antigen Receptor T cells \[CABA-201\]) in subjects with active, pemphigus vulgaris

Trial Details

NCT Number	NCT04422912
Lead Sponsor	Cabaletta Bio
Conditions	Pemphigus Vulgaris
Enrollment	40 participants
Start Date	2020-09-29
Primary Completion	2029-01 (estimated)
Study Completion	2029-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-29